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EC number: 701-362-9
CAS number: -
The objective of this study was to
evaluate the potential acute toxicity of the test item following a
single oral administration (gavage) to rats.
This study was performed according to
the international guidelines (OECD No. 423 and Council Regulation No.
440/2008 of 30 May 2008, Part B.1tris) andin compliance with the
principles of Good Laboratory Practices.
The test item was administered once by
oral route (gavage) to three groups of three fasted female
Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was
prepared in corn oil.
Since no relevant toxicity data were
available for the estimation of a lethal dose-level and any existing
data have been taken into account by the Sponsor, the starting
dose-level was 300 mg/kg for ethical reasons. After the first assay, the
next higher dose-level of 2000 mg/kg was tested. Then, as no toxicity
was observed at this higher dose-level, the results were confirmed in
other females by using the same dose-level.
Each animal was observed at least once
a day for mortality and clinical signs for 15 days. Body weight was
recorded on day 1 and then on days 8 and 15.
On completion of the observation
period, the animals were sacrificed and then submitted for a macroscopic post-mortem
examination.Macroscopic lesions were preservedin buffered formalin
thendestroyed at the finalization of the study report as no microscopic
examination was performed.
No unscheduled deaths occurred during
Piloerection was observed between 1
and 3 hours and/or 4 hours after treatment in 2/3 females treated at 300
mg/kg. There were no clinical signs observed at the dose-level of 2000
When compared to CiToxLAB France
historical control data, a slightly lower body weight gain was noted in
females treated at 300 or 2000 mg/kg between day 1 and day 15.
The test item administration did not
induce any macroscopic changes.
The oral LD50of the test
item was higher than 2000 mg/kg in rats.
Therefore, the test item is not
classified as toxic or harmful by oral route according to the criteria
of CLP Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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